New gasket and braided hose range from BioPure sets the new standard for confident fluid path validation

New gasket and braided hose range from BioPure sets the new standard for confident fluid path validation

Important product additions to the BioPure range from Watson-Marlow Fluid Technology Group will reinforce the organisation’s position as the leading provider of technologies for complete high purity fluid path solutions.

BioPure has innovated a range of high purity Platinum-cured silicone gaskets and Platinum-cured silicone braided hoses, adding to its extensive range of fluid path components. Leading the market with the highest level of validation available and extractable data in line with BPOG guidelines, this technology is designed to meet the exacting requirements of biotechnology and pharmaceutical single-use applications; enabling users to simplify and expedite validation procedures.

Silicone gaskets

BioPure high purity Platinum-cured silicone gaskets are designed for bioprocessing applications where fluid path connections are needed. Each is precision engineered to achieve a smooth bore, contamination-free fluid path under clamping compression. They are designed in accordance with ASME-BPE standards and are ISO14644 Class 7 cleanroom manufactured and packed.

“When we engaged with customers at the design stage, they emphasised the need for solutions that simplify production operations, lower cGMP manufacturing costs and reduce process validation. This is precisely what we have delivered. With laser-etched LOT numbering on every part, these gaskets include post-sterilised validation to current USP, EP and FDA standards and extractable data is documented in line with BPOG guidelines.”

The gaskets are available in 10 size options from ½” to 8” unflanged, and in eight flanged size options from 1” to 8”. A perfect match with BioPure’s existing range of connectors and clamps, BioPure Platinum-cured silicone gaskets allow end users and OEMs to connect their single-use fluid paths with confidence.

Silicone braided hose

These single and double braided flexible hoses are designed for high pressure applications. The hoses offer excellent bend radius, while a continuously extruded silicone bore assures the integrity of the contacting fluid. The new hoses are also able to withstand repeated autoclave and sterilisation processes.

BioPure Platinum-cured silicone braided hose is manufactured and packed within an ISO14644 Class 7 cleanroom environment thereby giving users full batch traceability to raw material. Similarly, hose is supported by industry leading validation and extractable data. A total of 10 inner diameter sizes for single braided hose are available from 0.125” to 1”, while double braided hose comes in ½”, ¾” and 1” internal diameters.